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NCT02657889 · OUTCOME

Phase 2: Plasma Concentrations of Major Metabolite of Niraparib (M1)

Niraparib in Combination With Pembrolizumab in Patients With Triple-negative Breast Cancer or Ovarian Cancer · Source last updated 2022-12-01

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Measure
MEDIAN
Unit
Nanograms per milliliter
Interval / dispersion
Standard Deviation
Time frame
Pre-dose and 2 Hours post-dose on Cycle 1 Day 1; Pre-dose and 2 Hours post-dose on Cycle 2 Day 1 (each cycle of 21 days)

What was measured

Blood samples were collected by sparse PK sampling to analyze plasma concentration of major metabolite of Niraparib (M1).

Analysis population: Pharmacokinetic Analysis Set. Only those participants with data available at the specified time points were analyzed.

Groups in this outcome

Phase 2 OC: Niraparib 200 mg + Pembrolizumab

Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

Phase 2 TNBC: Niraparib 200mg + Pembrolizumab

Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.

Group identifiers and denominators belong to this outcome only. They may differ in another outcome or in safety reporting.

Analysis denominator · Participants

GroupSource count
Phase 2 OC: Niraparib 200 mg + Pembrolizumab50
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab54

Reported measurements

Cycle 1 Day 1; Predose

Analysis denominator · Participants

GroupSource count
Phase 2 OC: Niraparib 200 mg + Pembrolizumab49
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab51
Values in Nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 OC: Niraparib 200 mg + Pembrolizumab0.0000.000Not reportedNot reportedNot reported
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab0.0000.000Not reportedNot reportedNot reported
Cycle 1 Day1; 2 hours post dose

Analysis denominator · Participants

GroupSource count
Phase 2 OC: Niraparib 200 mg + Pembrolizumab48
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab52
Values in Nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 OC: Niraparib 200 mg + Pembrolizumab116.66689.108Not reportedNot reportedNot reported
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab84.87592.206Not reportedNot reportedNot reported
Cycle 2 Day 1; Predose

Analysis denominator · Participants

GroupSource count
Phase 2 OC: Niraparib 200 mg + Pembrolizumab27
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab26
Values in Nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 OC: Niraparib 200 mg + Pembrolizumab1278.926625.932Not reportedNot reportedNot reported
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab1070.923648.225Not reportedNot reportedNot reported
Cycle 2 Day 1; 2 hours post dose

Analysis denominator · Participants

GroupSource count
Phase 2 OC: Niraparib 200 mg + Pembrolizumab28
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab27
Values in Nanograms per milliliter · Interval/dispersion: Standard Deviation
GroupValueSpreadLowerUpperComment
Phase 2 OC: Niraparib 200 mg + Pembrolizumab1500.143976.572Not reportedNot reportedNot reported
Phase 2 TNBC: Niraparib 200mg + Pembrolizumab1205.444858.698Not reportedNot reportedNot reported
Complete source fields
classes
  1. categories
    1. measurements
      1. group Id
        OG000
        spread
        0.000
        value
        0.000
      2. group Id
        OG001
        spread
        0.000
        value
        0.000
    denoms
    1. counts
      1. group Id
        OG000
        value
        49
      2. group Id
        OG001
        value
        51
      units
      Participants
    title
    Cycle 1 Day 1; Predose
  2. categories
    1. measurements
      1. group Id
        OG000
        spread
        89.108
        value
        116.666
      2. group Id
        OG001
        spread
        92.206
        value
        84.875
    denoms
    1. counts
      1. group Id
        OG000
        value
        48
      2. group Id
        OG001
        value
        52
      units
      Participants
    title
    Cycle 1 Day1; 2 hours post dose
  3. categories
    1. measurements
      1. group Id
        OG000
        spread
        625.932
        value
        1278.926
      2. group Id
        OG001
        spread
        648.225
        value
        1070.923
    denoms
    1. counts
      1. group Id
        OG000
        value
        27
      2. group Id
        OG001
        value
        26
      units
      Participants
    title
    Cycle 2 Day 1; Predose
  4. categories
    1. measurements
      1. group Id
        OG000
        spread
        976.572
        value
        1500.143
      2. group Id
        OG001
        spread
        858.698
        value
        1205.444
    denoms
    1. counts
      1. group Id
        OG000
        value
        28
      2. group Id
        OG001
        value
        27
      units
      Participants
    title
    Cycle 2 Day 1; 2 hours post dose
denoms
  1. counts
    1. group Id
      OG000
      value
      50
    2. group Id
      OG001
      value
      54
    units
    Participants
description
Blood samples were collected by sparse PK sampling to analyze plasma concentration of major metabolite of Niraparib (M1).
dispersion Type
Standard Deviation
groups
  1. description
    Participants with Ovarian Cancer (OC) received recommended phase 2 dose (RP2D) of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    OG000
    title
    Phase 2 OC: Niraparib 200 mg + Pembrolizumab
  2. description
    Participants with Triple Negative Breast Cancer (TNBC) received RP2D of Niraparib 200 mg orally once daily and Pembrolizumab 200 mg IV on Day 1 of each 21-day cycle.
    id
    OG001
    title
    Phase 2 TNBC: Niraparib 200mg + Pembrolizumab
param Type
MEDIAN
population Description
Pharmacokinetic Analysis Set. Only those participants with data available at the specified time points were analyzed.
reporting Status
POSTED
time Frame
Pre-dose and 2 Hours post-dose on Cycle 1 Day 1; Pre-dose and 2 Hours post-dose on Cycle 2 Day 1 (each cycle of 21 days)
title
Phase 2: Plasma Concentrations of Major Metabolite of Niraparib (M1)
type
SECONDARY
unit Of Measure
Nanograms per milliliter

Download exact source JSON → · Snapshot ctgov-results-191f4516d4760045304b24a0

Preserved source evidence · Not medical advice